Trial results for a study comparing different radiation therapy schedules for Breast Cancer were posted on ClinicalTrials.gov on 2026-05-07. The study found that patients receiving 10-fraction whole breast radiotherapy experienced a lower proportion of acute toxicity grade ≥ 2 (0.095) compared to those receiving 15-fraction therapy (0.1624365482233) up to one month post-treatment.
Background
Breast cancer is a common malignancy, and radiation therapy is a standard component of treatment for many patients following surgery. Traditional radiation regimens often involve multiple fractions over several weeks, which can pose logistical challenges and impact patient quality of life. Accelerated partial breast irradiation and hypofractionated whole breast irradiation have emerged as strategies to reduce treatment duration while maintaining efficacy and safety. This trial specifically investigated the acute toxicity profile of a more accelerated 10-fraction regimen compared to a standard 15-fraction schedule for certain stages of breast cancer.
Trial design
The Prospective Randomized Study of Accelerated Radiation Therapy (PRART), identified as NCT04175210, is a Phase 3, active but not recruiting trial that enrolled 397 participants. The study focused on patients with Breast Cancer, specifically Stage 0 ductal carcinoma in situ (Tis (DCIS), Stage T1-T2, lymph node negative (N0) breast cancers. Participants were randomized to receive whole breast radiotherapy with a concomitant boost to the tumor bed in one of two arms:
- Arm 1 (standard): 4050cGY and Boost to Tumor Bed of 4800cGY in 15 fractions.
- Arm 2 (experimental): 3200cGY and Boost to Tumor Bed of 4200cGY in 10 fractions.
The primary outcome measured was the "Proportion of Patients With Acute Toxicity Grade ≥ 2 on the 10-fraction Arm Compared to Proportion of Patients With Acute Toxicity Grade ≥ 2 on the 15-fraction Arm Evaluated up to 1-month Post-radiation Treatment."
Key results
The key measurements for the primary outcome, "Proportion of Patients With Acute Toxicity Grade ≥ 2 on the 10-fraction Arm Compared to Proportion of Patients With Acute Toxicity Grade ≥ 2 on the 15-fraction Arm Evaluated up to 1-month Post-radiation Treatment," were as follows:
- For ARM 1-4050cGY and Boost to Tumor Bed of 4800cGY in 15fractions, the proportion of participants with acute toxicity grade ≥ 2 was 0.1624365482233.
- For ARM 2 - 3200cGY and Boost to Tumor Bed of 4200cGY -10fractions, the proportion of participants with acute toxicity grade ≥ 2 was 0.095.
What this means
The results suggest that the accelerated 10-fraction radiation therapy regimen for specific stages of breast cancer may be associated with a more favorable acute toxicity profile compared to the standard 15-fraction regimen. A lower proportion of acute toxicity grade ≥ 2 in the 10-fraction arm could translate to improved patient comfort and fewer treatment-related side effects in the immediate post-radiation period. This finding holds potential implications for optimizing treatment schedules, potentially offering a shorter, equally effective, and less toxic option for eligible breast cancer patients, which could also enhance patient access and reduce healthcare resource utilization.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04175210, titled "Prospective Randomized Study of Accelerated Radiation Therapy (PRART)," were posted on 2026-05-07 on clinicaltrials.gov.